HIV InfectionsPhase 2NCT00126880
AVX754 (a New Nucleoside Reverse Transcriptase Inhibitor [NRTI]) to Treat Drug-resistant HIV
A Phase 2 study testing AVX754 and 3TC in people with HIV Infections, run by Avexa at 1 site in Australia.
Trial summary
The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is in treating HIV-1 infected people who have failed treatment with lamivudine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- AVX754 and 3TC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2005to Jan 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infected
- M184V mutation in reverse transcriptase
- Currently taking lamivudine
- Viral load >2000 copies/ml
Who cannot join
- Hepatitis B surface antigen positive
- Pregnant or breastfeeding females
- Hepatitis C RNA positive and requiring treatment
Trial locations and contacts
1 site in 1 country.
Australia1 site
Avexa (co-ordinating sites in Australia and Argentina)
Melbourne, Victoria, 3121
About this study
Official title: A Phase II, Randomised, Double-blind, Dose-ranging Study of AVX754 Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V Mutation in Reverse Transcriptase
The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is in treating HIV-1 infected people who have failed treatment with lamivudine.
Read the detailed description
Lamivudine or emtricitabine are commonly used in combination with other drugs for first-line treatment of HIV infection. Although effective initially, many people later on develop resistance to some or all of the drugs (including lamivudine) leading to virological failure. Resistance is associated with characteristic mutations, which for lamivudine is the M184V mutation. A change to new, active drugs must take place when patients fail their current regime, to regain control of the virus. Although there are other types of drugs available for second line treatment, there is currently no fully active, well tolerated cytidine analogue that can replace lamivudine in a second-line regimen when patients fail first line treatment. This study will measure the efficacy and safety of AVX754 (a novel cytidine analogue with activity against HIV resistant to other nucleosides) as part of a new regimen to treat patients who have failed treatment containing lamivudine, compared to the best alternative new regimen which continues to include lamivudine.
- Conditions
- HIV Infections
- Being tested
- AVX754, 3TC
- Keywords
- Human Immunodeficiency Virus, anti-retroviral therapy, nucleoside analogue, reverse transcriptase, lamivudine, resistance mutation, Treatment Experienced
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVX754Drug
Also called apricitabine
apricitabine, 600mg BID or 800mg BID
3TCDrug
Also called lamivudine
3TC, 150mg BID
| Study group | Role | What they receive |
|---|---|---|
| 600mg BID ATC | Experimental | 600mg BID ATC Receives: Drug: AVX754 |
| 800mg BID ATC | Experimental | 800mg BID ATC Receives: Drug: AVX754 |
| 150mg BID 3TC | Active comparator | 150mg BID 3TC Receives: Drug: 3TC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in HIV RNA levels at day 21
Measured: day 21
Time-weighted average change from baseline in HIV RNA levels through 21 days
Measured: 21 days
Secondary outcomes (3)
Change from baseline in HIV RNA levels at days 7, 14, 21
Measured: days 7, 14, 21
Proportion of subjects with HIV RNA levels <400 or <50 at days 7, 14, 21, and weeks 24 and 48
Measured: days 7, 14, 21, and weeks 24 and 48
Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21 and weeks 24 and 48
Measured: day 21 and weeks 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study startJul 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avexa
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Susan W Cox, Ph D, Study director, Avexa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126880
- Sponsor's protocol ID
- AVX-201
- Status last verified
- Jun 2011
- First submitted
- 3 Aug 2005
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised, Double-blind, Dose-ranging Study of AVX754 Versus Lamivudine in Treatment-experienced HIV-1 Infected Patients With the M184V Mutation in Reverse Transcriptase
- ClinicalTrials.gov ID
- NCT00126880
- Acronym / sponsor ID
- AVX-201
- Conditions
- HIV Infections
- Keywords
- Human Immunodeficiency Virus, anti-retroviral therapy, nucleoside analogue, reverse transcriptase, lamivudine, resistance mutation, Treatment Experienced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- AvexaIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 5 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will measure how safe and effective AVX754 (a new drug for the treatment of HIV) is in treating HIV-1 infected people who have failed treatment with lamivudine.
Detailed description
Lamivudine or emtricitabine are commonly used in combination with other drugs for first-line treatment of HIV infection. Although effective initially, many people later on develop resistance to some or all of the drugs (including lamivudine) leading to virological failure. Resistance is associated with characteristic mutations, which for lamivudine is the M184V mutation. A change to new, active drugs must take place when patients fail their current regime, to regain control of the virus. Although there are other types of drugs available for second line treatment, there is currently no fully active, well tolerated cytidine analogue that can replace lamivudine in a second-line regimen when patients fail first line treatment. This study will measure the efficacy and safety of AVX754 (a novel cytidine analogue with activity against HIV resistant to other nucleosides) as part of a new regimen to treat patients who have failed treatment containing lamivudine, compared to the best alternative new regimen which continues to include lamivudine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 600mg BID ATC | Experimental | Drug: AVX754600mg BID ATC |
| 800mg BID ATC | Experimental | Drug: AVX754800mg BID ATC |
| 150mg BID 3TC | Active comparator | Drug: 3TC150mg BID 3TC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HIV-1 infected
- M184V mutation in reverse transcriptase
- Currently taking lamivudine
- Viral load >2000 copies/ml
Key exclusion criteria (3 listed)
- Hepatitis B surface antigen positive
- Pregnant or breastfeeding females
- Hepatitis C RNA positive and requiring treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVX754Also: apricitabineapricitabine, 600mg BID or 800mg BID | Drug | 600mg BID ATC, 800mg BID ATC |
| 3TCAlso: lamivudine3TC, 150mg BID | Drug | 150mg BID 3TC |
Primary outcome
Change from baseline in HIV RNA levels at day 21
Time frame: day 21
Time-weighted average change from baseline in HIV RNA levels through 21 days
Time frame: 21 days
3 secondary outcomes
Change from baseline in HIV RNA levels at days 7, 14, 21
Time frame: days 7, 14, 21
Proportion of subjects with HIV RNA levels <400 or <50 at days 7, 14, 21, and weeks 24 and 48
Time frame: days 7, 14, 21, and weeks 24 and 48
Change from baseline and change in ratio of CD4+ and CD8+ cells at day 21 and weeks 24 and 48
Time frame: day 21 and weeks 24 and 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan W Cox, Ph D study director
Avexa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AVX754 and 3TC in people with HIV Infections, run by Avexa at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in HIV RNA levels at day 21 (time frame: day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.